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Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus

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ClinicalTrials.gov Identifier: NCT03036137
Recruitment Status : Unknown
Verified January 2017 by Dayse da Silva Souza, Federal University of Paraíba.
Recruitment status was:  Not yet recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Dayse da Silva Souza, Federal University of Paraíba

Brief Summary:
Relating the electroencephalogram findings of patients with tinnitus before and after a therapeutic modality is still scarce in the literature, especially with neuromodulatory methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n = 18) will be recruited for comparative purposes of brain electrical activity with and without tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale - VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be performed after 1 month of the end of treatment with tDCS.

Condition or disease Intervention/treatment Phase
Tinnitus Device: Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED
Estimated Study Start Date : February 1, 2017
Estimated Primary Completion Date : May 31, 2017
Estimated Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Active Comparator: Active tDCS
Subjects will receive 20 minutes of active tDCS for five consecutive days, current of 2 mA, in the temporoparietal left area, and right prefrontal cortex.
Device: Transcranial Direct Current Stimulation
Anodal stimulation of the temporoparietal left area with an cathode over the right dorsolateral prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.
Other Name: Direct current stimulator; Transcranial stimulator

Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.
Device: Sham Transcranial Direct Current Stimulation
Sham tDCS sessions will last 20 minutes
Other Name: Sham stimulation




Primary Outcome Measures :
  1. Tinnitus Handicap Inventory [ Time Frame: THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention. ]
    Assesses change in tinnitus from baseline to follow-up periods post interventions


Secondary Outcome Measures :
  1. Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress [ Time Frame: Visual analogue scale of tinnitus wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention. ]
    Self assessment of tinnitus loudness and tinnitus distress.

  2. Acuphenometry [ Time Frame: Acufhenometry wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention. ]
    Subjective assessment of the frequency, intensity and type of tinnitus.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of at least 18 years;
  • Chronic tinnitus for at least 6 months.
  • Age-adjusted normal (sensorineural) hearing

Exclusion Criteria:

  • Pregnancy and/or lactation;
  • Concurrent treatment for tinnitus;
  • Prior exposure to transcranial direct current stimulation (tDCS);
  • History of epilepsy and/or seizures;
  • Electronic implants or metallic objects in body;
  • Skin conditions where electrodes will be applied;
  • Major neurological co-morbidities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036137


Contacts
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Contact: Dayse Souza dayse.s.s@hotmail.com

Locations
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Brazil
Dayse Souza Not yet recruiting
Joao Pessoa, PB, Brazil
Sponsors and Collaborators
Federal University of Paraíba

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Responsible Party: Dayse da Silva Souza, Principal Investigator, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT03036137     History of Changes
Other Study ID Numbers: 61192416.9.0000.5188
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dayse da Silva Souza, Federal University of Paraíba:
Tinnitus
Electroencephalogram
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms